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  5. Label Information: Cough Relief

FDA Label for Cough Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. DISTRIBUTED BY:
    15. DISPLAY PANEL

Cough Relief Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredient (In Each Tablet)



Dextromethorphan HBr 15 mg


Purpose



Cough suppressant


Uses



temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold


Warnings



Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


Ask A Doctor Before Use If You Have



• a cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema


Stop Use And Ask A Doctor If



cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



  • do not take more than 8 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age
    •  adults & children 12 years & over take 2 softgels every 6 to 8 hours, as needed
     children under 12 years of age do not use


Other Information



• store at 20–25°C (68–77°F) • avoid excessive heat above 40°C (104°F) • protect from light


Inactive Ingredients



FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone,sorbitol sorbitan solution, titanium dioxide


Questions Or Comments?



1-888-333-9792


Distributed By:



Cabinet Health P.B.C.


Display Panel



PACKAGE NOT CHILD-RESISTANT

CABINET

Cough Relief

Active ingredient: DEXTROMETHORPHAN HBr 15 MG

Cough Suppressant

Relieves Cough up to 8 Hours

Non-Drowsy

Non-Narcotic

CABINET: The Sustainable Healthcare Co.™


* Please review the disclaimer below.